# Amicus Brief — United States v. Rutherford

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Brief
- **Published:** January 1, 1979
- **Citation:** 442 U.S. 544

## Text

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APR § 1979

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IN THE
Supreme Court of the Unite

QOOCTOBER TERM, 1078

No. 78-605

UNITED STATES OF AMERICA, et al.,

Petitioners,
v.

GLEN L. RUTHERFORD, et al.,

Respondents.

Brief Amicus Curiae of The McNaughton Foundation
of California on Behalf of Robert Stickle,
Steve Gadler, Dorothy Schires and Mrs. Doris Keith
Representing a Class of Cancer Patients

STEPHEN TORNAY
Attorney at Law
1831 Fourth Avenue
San Diego, California 92101
Telephone: (714) 232-7171

Attorney for Amicus Curiae

INTERIM PRINTING & MAILING COMPANY
1105 West MORENA BOULEVARD, SAN DIEGO, CALIFORNIA 92110 — 275-3050

i.
TABLE OF CONTENTS

INTEREST OF AMICUS CURIAE ,,,,.,.....5,
SUMMARY OF ARGUMENT ............00008:

QUESTIONS PRESENTED .............eeeeeee

ARGUMENT

I,

II.

WHETHER THE SAFETY AND EFFEC-
TIVENESS REQUIREMENTS OF THE
FEDERAL FOOD, DRUG AND COSME.-
TIC ACT SHOULD BE APPLIED TO
INJECTABLE LAETRILE INTENDED
FOR USE BY TERMINALLY ILL
CANCER PATIENTS WHEN PROCURED
BY A CERTIFIED LICENSED MEDICAL
FRFERTRETEEE S00 intedenrdiacenereres

WHETHER THE JUDGMENT OF THE
TENTH CIRCUIT COURT OF APPEALS
CAN BE UPHELD BY THE HOLDING OF
THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF
OKLAHOMA THAT THE DENIAL OF
THE USE BY A TERMINALLY ILL
CANCER PATIENT OF LAETRILE
UNDER THE SUPERVISION OF A
PHYSICIAN INVADES THE PATIENT'S
RIGHT OF PRIVACY ............eceeees

CT 5 ha Gees coeabeeaevenens I¥0 ee neas

16
24

“- ° ii

TABLE OF AUTHORITIES CITED TABLE OF AUTHORITIES CITED (Continued)
Page Page
CASES CASES (Continued)
Doe v. Bolton, 410 U.S. 179 (1978) ...cccccceeees i9 United Statea v, General Research Laboratories,
307 F.Supp. 197 (C.D. Cal. 1078) ..cccccccees 6
Dombrowaki v, Pfister, 380 U.S, 479 (1965) ..... 22
: | United States v, Spectro Fooda Corporation,
Eisenstadt v, Baird, 405 U.S, — (1972) ......5. 19 | Civ, - 76-101 (District N.J, 1976) affirmed in
| ' d ' fas
Holy Trinity Church v, United States, | on a selena 6
BN es cecis er tutcnskccvsasess: 22 sas ar 7 ee
; U.S, v, 250 Jara, ete, of U.S, Fancy Pure Honey,
Loving v. Virginia, 388 U.S. 1 (1967) v....ssie, 19 (D.C. Mich, 1963) 218 F.Supp. 208, affirmed
Olmatead v, United States, 227 U.S, 438 ..,...., 18 B44 Fidd 288 vieiiveseeesseseeneneneneneneens 7
People of the State of California v, Privitera, et al,,
WR Woo rnda cdbadeecar iene 20 TEXTS
* is ; ley 2
Pierce v, Society of Sisters, 268 U.S, 510 (1925) , i9 A Clinical Trial of Laetrile (Amygdalin) in the
Treatment of Advanced Cancer,
Prince v, Massachusetts, 321 U.S, 158 (1944) .,. 19 Dr, Charlea G, Moertel, M.D. oo... cc cece, 11
Roe v, Wade, 410 U.S, 113 (1978) voice ces 19 California Laetrile Report, VBI occ ccs 19
Roe v. Whalen, 429 U.S, B99 wo. cc cece cece eee ees 19 Cancer Facta and Figurea,
American Cancer Society, 1977) .........0055 4
Rutherford v, United States,
399 f.Supp. 1208 (W.D, Okla, 1979), 424 F.Supp. | Sanda, Statutes and Statutory Conatruction
566-168 (WB. GER, EBTHD ce cccccccevescccesr 6,15 (4th ed, 1973), Section 58.04 ...cccccccceeees 22
Rutherford v, United States, 498 F.Supp, 1287 ,, 8,17 Toxie Conatituenta of Plant Food Stuffa,
Pane eee C.H, 5, R. D, Montgomery,
Rutherford v, United States, 582 F.2d 1234 .,,.. 5 Academy Press, 1969 ........csccccccececes 6

Skinner v, Oklahoma, 316 U.S, 535 (1942) ..,... 19

» ie

TABLE OF AUTHORITIES CITED (Continued)

Page
MISCELLANEOUS
California Health and Safety Code,
LE sv ba bin hue Salen ch ee OK bhi a OKON 20
ELE | sn Ga EV ead beens unae snub nshte 20
Supreme Court Rule 42(1) vc. ccccccceeeeeeeeeeees |
21 U.S.C,
SN EE 2. ons woes 0 60 Gad4useN eee 5,9
EN, tbc ic Aweduv ahiod odeeebendeeieds 20

IN THE
Supreme Court of the United States

OCTOBER TERM, 1978

No, 78-605

UNITED STATES OF AMERICA, et al,,

Petitioners,
u,

GLEN L, RUTHERFORD, et al,,

Reapondenta,

Brief of Amicus Curiae of The McNaughton Foundation
of California on Behalf of Robert Stickle,
Steve Gadler, Dorothy Schires and Mrs, Doris Keith
Representing a Class of Cancer Patients

INTEREST OF AMICUS CURIAE

Pursuant to Supreme Court Rule 42(1), thia Amicua Curiae
brief ia submitted on behalf of the class of persona described
as American cancer patienta who have gone to the Republic of
Mexico to receive treatment for cancer including the use of
laetrile, These patienta number in the thousands, One clinic,
Centro Medico Delmar, Tiguana, Mexico, has served in excess

_ -

of 15,500 patients since 1974 and currently is receiving
patients from the United States at the rate of approximately
3,700 new patients annually. Clinica Cydel, Tijuana, Mexico,
has served approximately 3,500 patients since opening its
doors and is receiving patients from the United States at the
approximate rate of 850 new patients annually.

The staff of these facilities reveal that approximately eighty
percent (80%) of the United States patients have come to these
clinics after having been advised that their condition is
terminal, conventional medicine can give them no further
help; they seek treatment with laetrile as a last resort.

Treatment in Mexico by the clinics consists of a special diet,
vitamins, minerals and enzymes; adequate rest and exercise;
injectable and oral laetrile. Radiation therapy, conventional
chemotherapy and surgery are used by these clinics at the
discretion of the clinic’s medical director.

The average stay in Mexico is approximately three weeks.
Some patients stay at motels near the border in San Ysidro,
California, and travel each day to the clinics approximately
ten to fifteen miles away. Some patients stay at motels in
Tijuana or in small bungalows provided by the clinics at a
moderate rate of $14.00 per day for double occupancy. After
approximately three weeks, the patient’s initial course of
treatment has been completed and many of the patients have
improved to the point where they are ready to continue their
treatment at home in the United States. The patient is
supplied with a quantity of laetrile, both injectable and oral,
as is determined by his attending physician. This initial
supply is brought into the United States by the patient upon

i

presentation of the physician’s affidavit and payment of

applicable customs duties.

The vast majority of these returning patients desire to
continue treatment with laetrile at their homes in the United
States. It is at this point that the class of patients in whose
interest this brief is being submitted emerges. Under the
current affidavit system in use they are permitted to obtain
additional supplies upon presentation of the physician’s
affidavit and the appointment of a properly designated agent
for the importation of laetrile. It is this class of patients that
will require appropriate relief from this Honorable Court in
order to continue vheir treatment. The vast majority of these
patients experience varying degrees of relief and benefits.
These patients are generally free from pain without the use of
narcotics; the quality of their lives is improved and the length
extended.

SUMMARY OF ARGUMENT

Amicus concurs in the decision of the Tenth Cir-uit Court of
Appeals but requests that this Court should expand the relief
granted to the class of patients to include laetrile for oral
administration. Whether on the grounds of a determination
that the terms “safety” and “effectiveness” have no meaning
to the terminally ill cancer patient or on the grounds of right
of privacy. Access to laetrile, both intravenous and oral,
should not be denied these patients until the clinical trials to
be conducted under the direction of the National Cancer
Institute, Department of Health, Education and Welfare, have
been completed. Amicus urges the continued use of the current
affidavit system pending the outcome of these clinical trials.

-
QUESTIONS PRESENTED
I.

WHETHER THE SAFETY AND EFFECTIVENESS
REQUIREMENTS OF THE FEDERAL FOOD, DRUG AND
COSMETIC ACT SHOULD BE APPLIED TO INJECTABLE
LAETRILE INTENDED FOR USE BY TERMINALLY ILL
CANCER PATIENTS WHEN PROCURED BY A CERTI-
FIED LICENSED MEDICAL PRACTITIONER.

II.

WHETHER THE JUDGMENT OF THE TENTH CIRCUIT
COURT OF APPEALS CAN BE UPHELD BY THE
HOLDING OF THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF OKLAHOMA THAT
THE DENIAL OF THE USE BY A TERMINALLY ILL
CANCER PATIENT OF LAETRILE UNDER THE SUPER-
VISION OF A PHYSICIAN INVADES THE PATIENT'S
RIGHT OF PRIVACY.

ay
ARGUMENT
I.

WHETHER THE SAFETY AND EFFECTIVENESS
REQUIREMENTS OF THE FEDERAL FOOD,
DRUG AND COSMETIC ACT SHOULD BE APPLIED
TO INJECTABLE LAETRILE INTENDED FOR USE
BY TERMINALLY ILL CANCER PATIENTS WHEN
PROCURED BY A CERTIFIED LICENSED
MEDICAL PRACTITIONER.

The Federal Food, Drug and Cosmetic Act (Act) defines a
new drug as a drug “not generally recognized by qualified
experts as safe and effective for its intended use,” 21 U.S.C.
321, p. 1.

The decision of the Tenth Circuit Court of Appeals,
Rutherford v. United States, 582 F.2d 1234, held that “as a
matter of law, that the safety and effectiveness requirements
of the statute as now written have no application to
terminally ill cancer patients who desire to take the drug
‘laetrile’ intravenously,” ibid. at page 1237. The Court further
limited the procurement of intravenous injections to persons
who are certified by a medical practitioner to be terminally ill
of cancer.

S

The Tenth Circuit, in effect, continued the relief granted the
patients in the United States District Court on grounds other
than that upon which such relief was based in the District
Court. Unfortunately, the relief limited the acquisition of
laetrile to injectable laetrile.'/

i/ The term laetrile is being used in this brief to avoid any
confusion that might come about by the use of the term amygdalin.
Footnote 1 continued on following page.

x

It is urged by Amicus that the Tenth Circuit was correct in
holding that the Commissioner of Food and Drugs
erroneously applied the Federal Food, Drug and Cosmetic Act
to the distribution of intravenous laetrile to terminally ill
cancer patients. It is strongly suggested that that portion of
the decree which permits only intravenous injections of

Footnote 1 continued

More properly, the subject matter being dealt with before the Court is
the substance amygdalin. Amygdalin is extracted from the kernels of
various fruits, mostly of the prunus species. Amygdalin is extracted
from peach, bitter almond, prune and apricot kernels. The most
available is apricot kernels, thus, most of the amygdalin that is
extracted is extracted from this source. The term lae:rile was first
“coined” by Dr. Ernst T. Krebs, Jr. and is now used interchangeably
with the term amygdalin. There have been several judicial
determinations that have equated laetrile and amygdalin. United
States v. Spectro Foods Corporation, Civ. - 76-101 (District N.J. 1976)
affirmed in part, reversed in part, 544 F.2d 1175 (3rd Cir. 1976);
United States v. General Research Laboratories, 397 F.Supp. 197
(C.D. Cal. 1975); Rutherford v. United States, 399 F.Supp. 1208, 1211
(W.D. Okla. 1979), 424 F.Supp. 105106 (W.D. Okla. 1977).
Cyanogenetic glucocides appear in many foods eaten by man
including cassava, sweet potato, yam, maize and millet, bamboo and
sugar cane, peas and beans (especially lima beans), kernel of
almond, lemon, lime, arple, par, cherry, apricot, prune, peach and
plum, (Toxic Constituents of Plant Food Stuffs, C.H. 5, R.D.
Montgomery, Academy Press, 1969). (Lest wrong impressions be
created by the title of the book “Toxic Constituents of Plant Food
Stuffs,” it should be noted that upon reading the article by R. D.
Montgomery, one would quickly conclude that virtually no danger
exists from ingestion of these food stuffs when eaten in normal
quantities.)

<s

laetrile should be broadened to include laetrile for administra-
tion by oral route.?/

(1) The rationale and basis upon which food, drugs and
cosmetics are regulated is to protect the unwary customers in
vital matters of health. U.S. v. 250 Jars, etc. of U.S. Fancy
Pure Honey, (D.C. Mich. 1963) 218 F.Supp. 208, affirmed 344
F.2d 288. The line of cases that characterize this as the |

2/ The current practice by experienced laetrile physicians in
Mexico is to commence the treatment of cancer patients with high
intravenous doses of laetrile. When the patient’s condition justifies it,
the patient is switched to a mixture of injectable as well as oral
laetrile. This is an integral part of the entire treatment given by these
physicians with laetrile. Undoubtedly, the ruling of the Tenth Circuit
expressed by inference a possible misunderstanding as to the toxicity
of laetrile by oral administration. The same Court also apparently
revealed its unfamiliarity with current clinical practice in the
administration of laetrile. It should be observed at this point that the
route of oral administration presents no danger to the cancer patient
when under the guidance of a licensed physician. Laetrile like any
other substance, can be ingested in toxic quantities but this is true of
many over-the-counter drugs sold without prescription and also of
prescription items. This is not a valid reason to withhold it when
recommended by a physician. The fears expressed by the U.S.
Government and some of the amicus briefs reveal a lack of under-
standing of the toxicity of laetrile. The American Cancer Society has
estimated that as many at 70,000 cancer patients in the United
States have received laetrile therapy. This would, by necessity,
include oral administration. The report of two deaths which are in
themselves suspect and inconclusive leaves much to be desired in
supporting claims of the toxicity of laetrile. It is estimated that as
many as 1200 deaths occur annually in the United States from
ingestion of aspirin. (Center for Disease Control, Atlanta, Georgia.)
Yet aspirin is freely available to anyone who wishes to purchase it.

i
4
rationale behind the act are numerous, repetitious and center

around the attempt to protect the consumer. The requirement
of both safety and effectiveness in new drugs as provided by
the Act is commendable and should be interpreted and
enforced in a rational manner so as to give effect to the under-
lying purpose. Perhaps it is unworthy to say, but a necessary
observation to make, that the safety and effectiveness require-
ments of the Federal Food, Drug and Cosmetic Act as related
to the treatment of cancer is and has been more a statement of
wishful thinking than a reality.

Unfortunately, statistics bear out the fact that virtually all
methods of treatment of capcerous conditions by accepted
modalities are neither “safe” nor “effective.”3/ & 4/

(Footnotes 3 and 4 are quoted from Judge Bohanon’s decision in
Rutherford v. United States, 438 F.Supp. 1287.)

3/ “ . ,. the treatments that are available are very often
disfiguring; they can be painful; they can be unpleasant; they can
even be risky.” Emil J. Freireich, Professor of Medicine at the
University of Texas, School of Medicine, Houston.

4/ 1977 Cancer Facts and Figures by the American Cancer
Society estimates that 1977 will have produced an estimated 690,000
new cancer cases; and that over 54 million Americans now living will
eventually have cancer, whichis one out of every four Americans
living. The pamphlet also states that over the years cancer will strike
in approximately two of every three families, that in the 1970's there
will be an estimated 3.5 million cancer deaths, 6.5 million new cancer
cases, and more than 10 million people under medical care for cancer.
Only about 1/3 of all people who get cancer this year will be alive five
years after treatment, according to the publication.

-9-

It is therefore submitted that exceptions to the safety and
effectiveness requirements of the Food and Drug
Administration have been carved out when dealing with
cancer since drugs that are neither safe nor effective have
been approved.

Safety is described in the brief by the United States by way
of footnote at page 31, footnote 18, ‘(A) a drug is safe when the
expected therapeutic gain justifies the risk entailed in using
it...”, Dr. Theodore G. Klumpp, Chief Drug Division, F.D.A.
June 23, 1941.

Therefore, it appears that safety as a term is used in the
relative context in relation to the risk involved. Effectiveness
relates only to general recognition among “experts qualified
by scientific training and experience to evaluate the safety
and effectiveness of drugs as safe and effective for such
use...”, 21 U.S.C. 321 p. 1.

The foregoing provides little guidance and in the light of the
current methods of treatment for cancer, afford little
assurance to the cancer patient.

The Tenth Circuit Court of Appeals was able to perceive this
within the narrow limitation set forth by that Court. The ,
decision is limited to terminally ill cancer patients and is
further limited to intravenous injections of laetrile procured
by a licensed practitioner. The Court cited no authority fo rits
decision. Perhaps no such authority exists. However, this
Honorable Court has never been bound by authority nor
shackled by precedent. In enacting a statutory scheme of
reguiation such as the Federal Food, Drug.and Cosmetic Act,
Congress can never be expected to spell out conditions for all

- 10-

circumstances that may arise in the complex nature of our
societies. It is for the judiciary, therefore, to sometimes
interpret a statute amidst the realities of life and to base its
decision on grounds of reason and principle apart from
authority.

The Tenth Circuit Court of Appeals in its decision revealed
a depth of understanding of the terminally ill cancer patient’s
problems. The decision should be upheld but it is again
suggested that the Court expand the relief granted to include
access to laetrile in the oral administration form.

(2) The brief filed by the United States and that of two
amicus briefs (Commonwealth of Massachusetts, State of
California) have in greater or lesser degrees claimed inherent
dangers from the use of laetrile due to its toxicity and further
due to its ineffectiveness. Neither isue is properly before the
Court but if unanswered, wrong impressions could be created.
Therefore, a few comments should be made relative to these
two subject matters.

Initially, it should be observed that as of this date (March,
1979) eighteen states in the United States have legalized the’
sale, and/or manufacture, of laetrile within those states.°/

5/ The following states have already legalized laetrile: Arizona,
Alaska, Washington, Oregon, Idaho, Nevada, North Dakota, South
Daketa, Kansas, Oklahoma, Texas, Louisiana, Florida, Illinois,
Indiana, Maryland, New Hampshire, and New Jersey. (Bills have
passed in one house of the State Legislature of the states of Michigan
and Montana.) It is anticipated with reasonable certainty that a
majority of the states will have legalized laetrile within the next year
or two.

. =

Amicus will ask the Court to take judicial notice that the
legislative bodies of each of the several states have hearings
and testimony offered, both pro and con, when considering a
bill involving a substance that has apparently been as
controversial as laetrile. Amicus will further request the Court
to take judicial notice that each of these States, in the exercise
of it(s) respective police powers, is primarily concerned with
the safety, health and welfare of its citizens. Accordingly,
based on this rather overwhelming indication of confidence
as expressed by the legislative bodies of the states footnoted
below, it becomes apparent that the toxicity claims are
appreciably dissipated and the claims of ineffectiveness are
similarly suspect. It is not the purpose or the function of this
brief to delve into the effectiveness or into the safety of laetrile
although on each of these factors, the Court would
undoubtedly find some input useful.

The Court should be informed that currently the prestigious
Mayo Clinic in Rochester, Minnesota, 55901, is designing a
common protocol for the five institutions which have been
selected by the National Cancer Institute, Department of
Health, Education and Welfare, to carry out the forthcoming
clinical trials of laetrile. In a copy of the proposed clinical trial
obtained through the Freedom of Information Act, the
following statement by Dr. Charles G. Moertel, M.D., of the
Mayo Clinic appears as an introductory to the protocol for the
clinical trials.*/

6/ A Clinical Trial of Laetrile (Amygdalin) in the Treatment of
Advanced Cancer

I. Introduction
Laetrile (Amygdalin, Vitamin B-17) is one of the many natural
cyanogenic glycosides. This substance was perhaps first isolated by
Footnote 6 continued on following page.

Fr

Thus, finally, adequate clinical triala are about to be
commenced in which the question of efficacy will soon be

“

Footnote 6 continued

German chemists in 1832 and it was listed in the Merck Index in the
late 19th century with no defined therapeutic indication.
Current use of Laetrile, dating from the early 1950's, can be

ascribed to Dr. Ernest T. Krebs Jr. who theorized 1) Laetrile is.

metabolized by mammalian cells with the release of cyanide, 2)
Detoxification of cyanide by the normal cell occurs promptly,
converting free cyanide to thiocyanate, 3) An enzyme inhibition in
the cancer cell prevents this detoxification and the free cyanide is

therefore allowed to be specifically toxic to the cancer cell.
Animal tumor model studies of Laetrile have been generally stated
to show no antineoplastic activity. Initial studies conducted at
Memorial-Sloan Kettering by Kanematsu Sugiura, however, were
reported as showing delayed appearance and growth of pulmonary
metastasis in a spontaneous breast tumor system. He also claimed
temporary retardation of growth of small primaries, inhibition of
appearance of new tumors, and better health and appearance of
treated mice. Later studies at the same institution conducted by
Franz Schmidt guve results confirming the observations of Sugiura
in one study out of three and this was only at borderline significance.
The other two studies were negative. More recent investigations
directed by Daniel S. Martin, C. Chester Stock, and Elizabeth
Stockert have been uniformly negative. Some of these latter investi-
gations have been blinded and conducted with direct participation
by Doctor Sugiura. A large group of animal studies were also
conducted at the Southern Research Institute and were stated to be
negative, although analyses of these results by some have raised the
question of antitumor activity in one of three dosage levels tested.
Published negative evaluations in animal model systems also
include those of Hill et al (Cancer Res. 36:2102) and Wadinsky
(Cancer Chemother Rep 59:939). It must be concluded that in animal
tumor studies, the effect of Laetrile has probably been negligible.
Toxicity of Laetrile in dosages currently employed for human
cancer is assumed to be minimal, although toxic reactions have
never been systematically observed and recorded. Apparently the
Footnote 6 continued on following page.

1d:

anawered; the queation of efficacy belongs in the clinica not in
the courta,

Footnote 6 continued

only observed side effect is transient hypotension immediately
following injection, and this is exceedingly rare. Nausea and
vomiting have occurred infrequently after oral ingestion and these
symptoms are said to subside with continued use. Animal toxicology
studies of parenterally administered drug indicate that the dosages
currently employed clinically are far below those at which
significant toxic reactions would be anticipated. Toxicology of the
orally administered drug, however, reveals that there are species to
species differences. Though the dose tolerated in dogs is well above
that planned in this study the defined Lethal Dose in the monkey
and the rat is in the order of 2 grams/m?. This is in contrast to the

~ large clinical experience in humans where larger than proposed

doses are prescribed and administered with little to no reported
toxicity.

In the past, consideration of a clinical trial for Laetrile has been
rejected by the medical and scientific community on the basis of
inadequate preclinical evidence of antineoplastic activity. The usual

‘criteria for according a new drug high priority for clinical trial, as

established by both the National Cancer Institute and the Food and
Drug Administration, have included at least a reasonable demon-
stration of antineoplastic activity in animal tumors. Although
complete reliance on rodent tumor experience for admission of drugs
to human clinical trial can be scientifically questioned, such s
general policy seems reasonable in view of the lack of promising
alternative screening procedures for therapeutic activity. A case for
waving this precedent could only be made under exceptional
circumstances, but such circumstances do now seem to exist for
Laetrile. Today in the United States, Laetrile has become one of the
most commonly employed chemotherapeutic agents for the
treatment of cancer. It has been estimated that during 1977 some
2000 American practitioners were involved in administering over
1,000,000 grams of Laetrile per month to over 50,000 patients. From
the standpoint of magnitude of use alone, Laetrile has become a
public health issue of major significance.

Footnote 6 continued on following page.

Amicus, representing the class as set forth at the beginning
of thie brief, would like to briefly touch upon the method by

Footnote 6 continued

Most important with regard to the Laetrile question are the serious
social, economic, political, and legal issues which have surrounded it.
Organized medicine, the American Cancer Society, the National
Cancer Institute, and the Food and Drug Administration, have
previously taken strong stands against the use of Laetrile, but this
stance has not seemed to be acceptable to the general public.
Organized medicine has been depicted as depriving the dying cancer
patient of a harmless treatment that could conceivably provide
palliation, and, even if therapeutically inactive, could provide a
psychologically beneficial placebo effect. Laetrile has become one of
the most popular subject on the news media with heavy coverage in
newspapers, magazines, radio, and television. Prominent United
States Senators and Congressmen have called publically for a re-
evaluation of the Laetrile question and the Senate Subcommittee on
Health has held public hearing regarding Laetrile. On the state level,
Laetrile has been legalized for either human use of manufacture or
both in 17 of the 50 states. Any contention that these actions simply
represented a response to a vocal minority would seem to be
contradicted by a Harris poll in which a nationwide sampling
favored legalization of Laetrile by a strong 53 to 23 percent majority.
Laetrile has been, or is being. considered in 16 cases before Federal
Courts. In those cases which have been decided, the decisions have
overwhelmingly favored Laetrile. Use of Laetrile by the terminal
cancer patient has been made legal through Federal District Court
decision and this decision has been upheld by the Federal Court of
Appeals. This issue is now pending before the United States Supreme
Court. Laetrile is now allowed for treatment of any cancer patient,
requiring only a short form be filled out which states little more than
the patient has cancer and desire such treatment.

Certainly it may be argued that there is a segment of the American
public that will pursue quack treatment regardless of what evidence
is presented to them. The Laetrile issue, however, has clearly gone
far beyond the point of just another quack medicine. Sound, sensible
Americans are obviously confused and they are not convinced by the

Footnote 6 continued on following page.

7a.

which continued use of laetrile can be experienced by the
terminally ill cancer patienta pending the outcome of the
clinical triala about to be commenced,

Certain references have been made to the “affidavit
system.” Briefly, this is a system worked out following the
orders of the United States District Court for the Western
District of Oklahoma following the decision of that Court in
Rutherford v. United States, 499 F.Supp. 1208. In practice, the
system is one in which duly licensed physicians or court
approved foreign physicians, may sign affidavits. Cancer
patients then, with this affidavit in hand, can obtain their
supplies of laetrile as prescribed by their doctor.

Footnote 6 continued

arguments of Laetrile opponents or by the fact that Laetrile has no
activity in experimental animals. Their concern has been overtly
expressed by their elected representatives and by their Federal
Courts. The welfare of this large segment of the American public
cannot be dismissed with the argument that a handful of Laetrile
zealots will never be convinced regardless of evidence.

If Laetrile is indeed worthless and a cruel hoax for the cancer
victim, then the thinking, sensible American citizen should be
presented with convincing evidence that will serve to protect him
against such exploitation. If, on the other hand, the widespread
public acceptance of Laetrile is indicative of some useful palliative
effect, it is even more important that this effect be demonstrated in a
convincing manner.

Considering the scope and impact of the Laetrile issue today, there
would seem to be no reasonable alternative to a therapeutic trial
conducted with objective methodology by experienced clinical cancer
research groups whose results will be credible in the eyes of the
medical community, the communications media, and the American
public.

~ os

Amicus strenuously urges the Court that this system
(affidavit) should be continued pending the outcome of the
clinical tests on laetrile. The thousands of patients that
Amicus represents should not be made exiles from their own
country in order to continue their treatment. By granting the
relief requested, pending completion of the clinical trials of
laetrile by the National Cancer Institute, no conceivable harm
could be caused to the government’s position whereas
irreparable harm could be sustained by the thousands of
patients Amicus represents should the relief requested be
denied and the clinical trials demonstrates the efficacy of
laetrile.

II.

WHETHER THE JUDGMENT OF THE TENTH
CIRCUIT COURT OF APPEALS CAN BE UPHELD
BY THE HOLDING OF THE UNITED STATES
DISTRICT COURT FOR THE WESTERN DISTRICT
OF OKLAHOMA THAT THE DENIAL OF THE USE
BY A TERMINALLY ILL CANCER PATIENT OF
LAETRILE UNDER THE SUPERVISION OF A
PHYSICIAN INVADES THE PATIENT’S RIGHT
OF PRIVACY.

The government argues in its brief that a terminally ill
cancer patient enjoys no constitutional right of privacy which
would protect him against an intrusion by the United States
Government that would deny him access to the drug laetrile.

Three postulates are urged by the government. The first
suggests that (1) laetrile is toxic, the second (2) denies the
constitutional right of the patient to take a particular drug or

. e

class of drugs for medical purposes and the third (3) alleges
that even if such a constitutional right of privacy exists, such
right to use laetrile is outweighed by compelling government
interest in protecting the public health. Amicus contends that
the United States is wrong on all three postulates.

A. The government first urges that laetrile is toxic. It is
interesting to note that the District Court in which
nontoxicity was found is the Court in which the evidence was
reviewed. Questions of toxicity raised the spectre of possible
deaths and the Court was thus entrusted with the sacred task
of ruling on a possible death-dealing substance. The U.S.
District Court for the Western District of Oklahoma,
Rutherford v. United States, 438 F.Supp. 1287, found adequate
proof by people who had actually used laetrile, as opposed to
those who had not, that laetrile indeed was not toxic. The
question of toxicity, properly speaking, is not really before
this Court. The attempt at this late date to make it an issue
before the Court is beyond the scope of this appeal. However,
it would be appropriate to repeat that virtually every drug in
use today is toxic when ingested or administered by other
methods in excessive amounts. When laetrile is prescribed by
an attending physician, it is perfectly safe. It should also be
noted that a finding by the Commissioner that a drug is not
recognized as safe by qualified experts is not a determination
of toxicity. The range of safety does not limit itself to toxicity
but it involves safety in varying degrees. In any event, when
prescribed by a licensed medical practitioner, clearly there is
no danger or the spectre of any harm to any person.

B. Next, the government claims that there is no
constitutional right of privacy to use unproven or ineffective

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drugs. This untenable argument fails to consider the fact that
there are no safe drugs or treatments and there are no
effective drugs or treatments for the care, treatment or
prevention of cancer. Cast in this light, denial of even an
unproven or ineffective drug that gives the terminally ill
cancer patient hope and is taken by him under the guidance of
a physician invades the right of privacy as described by
Justice Brandeis in Olmstead v. United States, 227 U.S. 438,
478:

“(T fhe makers of our Constitution undertook to
secure conditions favorable to the pursuit of
happiness. They recognized the significance of
man’s spiritual nature, of his feelings and of
his intellect. They knew that only a part of the
pain, pleasure and satisfactions of life are to be
found in material things. They sought to
protect Americans in their beliefs, their
thoughts, their emotions and their sensations.
They conferred, as against the government, the
right to be let alone - - the most comprehensive
of rights and the right most valued by civilized
men. To protect, that right, evéry unjustifiable
intrusion by the government upon the privacy
of the individual, whatever the means
employed, must be deemed a violation. . . .”

The cancer patient is left upon the horns of a dilemma; he is
offered either unsafe and ineffective remedies sanctioned by
the Federal Government or a nontoxic naturally occurring
substance which has been present in the diet of man since
before the dawn of history. Faced with these alternatives, the
terminally ill cancer patient has, and understandably, fre-
quently selected laetrile as his method of treatment. Little has

_ e

been said about the improved quality of life that is achieved
by the patient receiving laetrile. Appetite is restored, weight
increases, pain reduces and the patient experiences an
increased sense of well-being. These are the findings of the
California Laetrile Report of 1953. Within the framework of
this circumstance the cancer patients represented by Amicus
assert a right of privacy to make this “important decision.” To
deny him this right is truly an invasion of an area of privacy
that has been long recognized by this Court in case after case.
This Court has recognized that the right of privacy exists in
many areas of our lives. Abortion, Roe v. Wade, 410 U.S. 113
(1973), Doe v. Bolton, 410 U.S. 179 (1973); marriage, Loving v.
Virginia, 388 U.S. 1 (1967); procreation, Skinner v. Oklahoma,
316 U.S. 535 (1942); contraception, Eisenstadt v. Baird, 405
U.S. (1972); family relationships, Prince v. Massachusetts,
321 U.S. 158 (1944); child rearing and education, Pierce v.
Society of Sisters, 268 U.S. 510 (1925). This Court has
described the breadth of the right as “. . . independence in
making certain kinds of important decisions.”’ Roe v. Whalen,
429 U.S. at 599-600. Important decisions are not limited to
those areas in which this Court has formerly found this
fundamental right to exist.

The Government argues at page 60 of its brief, “the right
claimed here of caring for one’s health by obtaining a
particular drug without government hindrance does not fall
into any of those categories.” A failure to fall “into any of
those categories” (former decisions) does not mean that the
right does not exist in other categories. In all probability, it is
partly for this reason that this case is before this Court.

-.

This is a case of first impression before this Court. There
can be little doubt that this decision, one of life and death, is
the type of “important decision” that this Court has
recognized in determining the parameters of the right of

privacy.

Recently the Supreme Court of the State of California, Sup.
Ct. No. CR-32978, ____ Cal.3d ____ (1979), had an opportunity
to rule on the constitutionality of a State Statute (Health and
Safety Code 1707.1) which provides for criminal sanctions to
any person, including a physician, who sells, delivers,
prescribes or administers any drug or device used in the
diagnosis, treatment, alleviation or cure of cancer which has
not been approved by the federal agency (21 U.S.C. Section
355) or by the State Board (Cancer Advisory Council) (Health
and Safety Code Section 1704).

Defendants, convicted under this statute, claimed a right of
privacy in the patient to receive laetrile, the physician
defendant claimed a derivative right from his patients. The
convictions had been reversed by the District Court of
Appeals in California, People of the State of California v.
Privitera, et al., 141 Cal.Rptr. 764, in a decision written by
Judge Robert O. Staniforth holding that both the doctors’ as
well as the patients’ right of privacy had been invaded. This
searching opinion became the opinion of the dissent and was
reprinted in the California Supreme Court. The logical
arguments of Judge Staniforth are barely resistable.
However, the Supreme Court held that the section under
scrutiny (1707.1 of the Health and Safety Code of the State of
California) did bear a reasonable relationship to the
achievement of a legitimate state interest in the health and
safety of its citizens.

- 21 -

It should be carefully pointed out, however, that this
decision is very narrow in its terms dealing strictly with the
constitutionality of the statute in the case under consideration
by that Court. A quotation from this case (with apologies for
lack of the page number) states as follows:

“Defendants can take no comfort in the Court
of Appeals decision for unlike Rutherford
(referring to 582 Fed. 2d, 1234), this case is not
an action on behalf of the class of terminally ill
cancer patients. Whatever may be said in favor
of permitting terminal cancer patients access
to laetrile, there is no indication in the records
that defendants sought to restrict their
activities to that class when prescribing, distri-
buting and administering laetrile. Indeed, the .
record reflects that Dr. Privitera sometimes
neither took a medical history from, nor per-
sonally examined the patients for whom he
prescribed laetrile. The lay defendants, of
course, were not qualified to diagnose cancer,
much less to determine whether a cancerous
condition was ‘terminal.’ ” (Emphasis by
Court)

Thus it would appear that the California Supreme Court did
recognize that terminally ill cancer patients fall within a
totally different class; as to them, the right of privacy might
easily have been found to exist for this class by the same
Court. Certainly this is a reasonable inference.

C. The third argument of the government on the right of
privacy contends that application of the safety and efficacy
requirement of the Food, Drug and Cosmetic Act to laetrile is
a reasonable means of serving a compelling government

- 22 -

interest in protecting the public health. Amicus agrees that
the “safe” and “effective” requirements of the Food, Drug and
Cosmetic Act are reasonable means of serving a compelling
government interest in protecting health. There is no quarrel
here. However, this broad statement is not reasonably related
to the application of laetrile for reasons previously stated. In
Sands, Statutes and Statutory Construction (4th ed. 1973),
Section 58.04, the following statement appears:

“Because of the deeply entrenched commit-
ment of western society and law to the values
of individualism, there is a pervasive
preference for interpretations of doubtful
statutes which favor individual rights. Thus
statutes which impinge on fundamental
freedoms are strictly construed.” Dombrowski
v. Pfister, 380 U.S. 479 (19665).

Also, from Holy Trinity Church v. United States, 143 U.S.
457 at 459 (1891):

“It is a familiar rule, that a thing may be
within the letter of the statute and yet not
within the statute, because not within its spirit,
nor within the intention of its makers . . . This
is not the substitution of the will of the judge
for that of the legislator, for frequently words
of general meaning are used in a statute, words
broad enough to include an act in question, and
yet a consideration of the whole legislation, or
of the circumstances surrounding its enact-
ment, or of the absurd results which follow
from giving such broad meaning to the words,
makes it unreasonable to believe that the legis-
lator intended to include the particular act.”

- 23 -

It must be remembered that the specific subject matter
before this Court is laetrile in its application only to termi-
nally ill cancer patients under the supervision of a licensed
physician. The Tenth Circuit Court’s decision based upon
reason and principle held that “safe and effective” require-
ments have no meaning to terminally ill cancer patients.
Whether the restriction on government regulation of laetrile is
thus obtained on a rule of statutory construction or on the
constitutional grounds of right of privacy makes little
difference to the suffering cancer patient who is told he is
about to die. The relief requested is what is needed.

Cancer patients should not be made “exiles” from thir own
country, they should not be required to go to foreign jurisdic-
tions in order to obtain the laetrile treatment which is a
treatment of their own choice.

Finally, it is worthy to comment and speculate that the
Tenth Circuit Court sensed the constitutional underpinnings
in its decision but indulged in a rule of statutory construction
to avoid the constitutional issue which is now before this
Court. It is urged that a right of privacy exists in a terminally
ill cancer patient to seek and obtain laetrile under the
guidance of his physician for his personal use without
unwarranted interference by the government.

- 24 -
CONCLUSION

For the reasons set forth in this brief it is respectfully urged
that the Tenth Circuit Court decision should be affirmed, the
relief expanded to include oral laetrile. Amicus recommends
that the affidavit system now in use should be continued
including oral laetrile pending the completion of the clinical
trials under the direction of the National Cancer Institute,
Department of Health, Education and Welfare.

Respectfully submitted,
STEPHEN TORNAY

Attorney for Amicus Curiae

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385005_1872%3A14. Public record. Not legal advice.